BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPILONG NRFIT® CATH

    MDR report key: 23580975 · Received November 18, 2025

    Report

    Report Number
    9611612-2025-00047
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 20, 2025
    Report Date
    January 14, 2026
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN#(B)(4). INCIDENT OCCURRED IN UK. THE COMPLAINED ITEM WAS A PROCEDURE PACK ACCORDING TO ARTICLE 22 UNDER EU REGULATION 2017/745. THEREFORE, UNDER SECTION SUSPECT MEDICAL DEVICE, THE DATA OF THE AFFECTED COMPONENT WERE LISTED. THE AFFECTED COMPONENT IS THE EPILONG CATHETER (SEE UNDER REFERENCE NUMBER). UPDATE 2026-01-14: IMDRF CODES A, C AND D WERE UPDATED ACCORDING TO INVESTIGATION RESULTS. FURTHERMORE, INVESTIGATION RESULTS WERE UPDATED IN THIS REPORT. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOME AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    IRN#(B)(4). INCIDENT OCCURRED IN UK. THE COMPLAINED ITEM WAS A PROCEDURE PACK ACCORDING TO ARTICLE 22 UNDER EU REGULATION 2017/745. THEREFORE, UNDER SECTION SUSPECT MEDICAL DEVICE, THE DATA OF THE AFFECTED COMPONENT WERE LISTED. THE AFFECTED COMPONENT IS THE EPILONG CATHETER (SEE UNDER REFERENCE NUMBER). INVESTIGATION IS ONGOING. FINAL EVALUATION CAN BE FOUND IN FINAL REPORT.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN UK DURING AN EPIDURAL CATHETER INSERTION ON LABOUR WARD, THE EPIDURAL CATHETER SNAPPED APPROXIMATELY 5CM FROM THE TIP. THE DISTAL 5CM OF CATHETER WAS DEEP INSIDE THE PATIENT'S BACK AND WAS SURGICALLY REMOVED.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN UK. DURING AN EPIDURAL CATHETER INSERTION ON LABOUR WARD, THE EPIDURAL CATHETER SNAPPED APPROXIMATELY 5CM FROM THE TIP. THE DISTAL 5CM OF CATHETER WAS DEEP INSIDE THE PATIENT'S BACK AND WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768215 EPILONG NRFIT® CATH EPILONG NRFIT® CATH CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 1552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention